Curosurf

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The initial recommended dose of Curosurf is 2.5 mL/kg birth weight. Curosurf may interact with other drugs. Tell your doctor all medications and supplements your child uses. Curosurf is intended for premature infants and is unlikely to be used in pregnant or breastfeeding women.

Our Curosurf (poractant alfa) Suspension Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

SIDE EFFECTS

Clinical Trials Experience

Because clinical studies are conducted under widely
varying conditions, adverse reaction rates observed in the clinical studies of
a drug cannot be directly compared to rates in the clinical studies of another
drug and may not reflect the rates observed in practice.

The safety data described below reflect exposure to
CUROSURF at a single dose of 2.5 mL/kg (200 mg/kg), in 78 infants of 700-2000
grams birth weight with RDS requiring mechanical ventilation and a FiO2 ≥
0.60 (Study 1) [seeClinical Studies]. A total of 144 infants were
studied after RDS developed and before 15 hours of age; 78 infants received
CUROSURF 2.5 mL/kg single dose (200 mg/kg), and 66 infants received control treatment
(disconnection form the ventilator and manual ventilation for 2 minutes).

Transient adverse effects seen with the administration of
CUROSURF included bradycardia, hypotension, endotracheal tube blockage, and
oxygen desaturation. The rates of the most common serious complications
associated with prematurity and RDS observed in Study 1 are shown in Table 2.

Table 2: Most Common Serious Complications Associated
with Prematurity and RDS in Study 1

CUROSURF 2.5 mL/kg
n=78

CONTROL*
n=66

Acquired Pneumonia

17%

21%

Acquired Septicemia

14%

18%

Bronchopulmonary Dysplasia

18%

22%

Intracranial Hemorrhage

51%

64%

Patent Ductus Arteriosus

60%

48%

Pneumothorax

21%

36%

Pulmonary Interstitial Emphysema

21%

38%

*Control patients were
disconnected from the ventilator and manually ventilated for 2 minutes. No
surfactant was instilled.

Seventy-six infants (45 treated
with CUROSURF) from study 1 were evaluated at 1 year of age and 73 infants (44
treated with CUROSURF) were evaluated at 2 years of age to assess for potential
long-term adverse reactions. Data from follow-up evaluations for weight and
length, persistent respiratory symptoms, incidence of cerebral palsy, visual
impairment, or auditory impairment was similar between treatment groups. In 16
patients (10 treated with CUROSURF and 6 controls) evaluated at 5.5 years of
age, the developmental quotient, derived using the Griffiths Mental
Developmental Scales, was similar between groups.

Immunogenicity

Immunological studies have not
demonstrated differences in levels of surfactant-anti-surfactant immune
complexes and anti-CUROSURF antibodies between patients treated with CUROSURF
and patients who received control treatment.

Postmarketing Experience

Pulmonary hemorrhage, a known
complication of premature birth and very low birth-weight, has been reported
both in clinical trials with CUROSURF and in postmarketing adverse event
reports in infants who had received CUROSURF.